MODULE 3 - PART 2 Flashcards
quality: practiced even from age of
craftsmanship & guilds.
definition of quality as consensually agrees by ____: “The degree to which a set of inherent characteristics fulfills requirement”
2005 (ISO 9000)
____: explicitly in a document
____: custom/ common practice for org, its customers & other interested parties.
stated; generally implied:
is process/system for monitoring the quality of lab testing.
Quality Control (QC)
TYPE OF QUALITY CONTROL:
➔ QC practice & performance in an indiv. lab using known concentrations.
➔ e.g w/ known concentrations inc. in-kit controls or third party controls.
Internal QC
TYPE OF QUALITY CONTROL:
➔ measures lab’s ability to obtain correct result on an unknown specimen.
➔ specimens are obtained thru quality assurance programs of private/ professional/ public orgs or thru various governmental agencies responsible for lab licensure.
External QC
TYPE OF EXAMINATION:
- measure quantity of analyte present in sample, & measurements need to be accurate and precise.
Quantitative Examination
TYPE OF EXAMINATION: measure the presence/ absence of substance, or evaluate cellular characteristics such as morphology.
Qualitative Examinations
TYPE OF EXAMINATION: results of these tests are expressed as an estimate of how much of the measured substance is present.
Semiquantitative Examinations
____ (1976) & ____ (1991), point out that lab’s testing cycle begins w/ doctor’s request for lab services & continues when info is received by the physician & new requests are issued.
Lundberg; Bozzo
address specific issues/ goals & are plans for ensuring compliance/ bringing about change
quality management programs
represent final results of all efforts & are the actual practices taking place.
operational system
evaluation of participant performance against pre-established criteria by inter lab comparisons (ISO 17043).
PROFICIENCY TESTING (PT)
for the purposes of ISO _____, proficiency testing is taken in its widest sense
ISO 17043
PT: quantify one or more measurands of the proficiency test item
Quantitative Scheme
